Product Code: PAG FDA class 2 21 CFR 878.3300

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

General, Plastic Surgery

The Mesh, Surgical, Non-Synthetic, Urogynecologic, for Stress Urinary Incontinence, Retropubic or Transobturator is a non-synthetic surgical mesh implant used for the transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency and/or urethral hypermobility. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is PAG, with regulation number 878.3300 under the General, Plastic Surgery specialty, reviewed by the gastroenterology/urology panel, and it carries an implant flag.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: PAG
Device Class: FDA class 2
Regulation Number: 878.3300
Medical Specialty: General, Plastic Surgery
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Definition

Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 9 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K090688	COOK UROLOGICAL GRAFT	Jul 10, 2009	Substantially Equivalent	Cook Biotech, Inc.
K050445	AMS COLLAGEN DERMAL MATRIX	Jun 17, 2005	Substantially Equivalent	American Medical Systems, Inc.
K042949	PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)	Nov 09, 2004	Substantially Equivalent	C.R. Bard, Inc.
K031295	BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM	May 15, 2003	Substantially Equivalent	C.R. Bard, Inc.
K030460	MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX	Mar 07, 2003	Substantially Equivalent	Brennen Medical, Inc.
K020654	STRATASIS SLING KIT	Apr 09, 2002	Substantially Equivalent	Cook Biotech, Inc.
K993459	MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX	Nov 05, 1999	Substantially Equivalent	Advanced Uroscience, Inc.
K992159	SURGISIS SLING	Sep 23, 1999	Substantially Equivalent	Cook Biotech, Inc.
K982403	BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX	Sep 22, 1998	Substantially Equivalent	Brennen Medical, Inc.